Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

No specific information exists on the toxicity of lysozyme, however considering that lysozyme is naturally occurring in many organisms, such as viruses, bacteria, plants, insects, birds, reptiles and mammals including humans and it is expected as non-toxic for aquatic and terrestrial life.

Furthermore based on common industrial practice no releases are expected, thus direct and indirect exposure is unlikely and no specific test is necessary. Additionally, Lysozyme is naturally present in the environment and in case releases occurred they would be minimal in relation to natural background concentrations.

Enzymes are proteins readily biodegradable; in nature, they are involved at any level of the food chain and in the microbial biodegradation. All enzyme classes are readily biodegradable and degradation products are primarily peptides and amino acids, then carbon dioxide and water which cause no harm to nature.

The bioconcentration can generally be neglected, due to the hydrophilic properties and ready biodegradability of proteins.

Conclusion on classification

Lysozyme hydrochloride does not meet the criteria to be considered as hazardous to the environment, thus, in accordance with CLP regulation (EC1272/2008), lysozyme hydrochloride is not classified as toxic to the environment.